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The Sonopsy aspiration needle is intended to percutaneously obtain abdominal tissue including the liver, prostate, kidney, breast, lymph node, and other soft tissues using ultrasonic visualization.

Needle size: 14G to 21G, 80 to 200mm Needle tip: Biopsy point Inner needle tip: pencil point or trocar point Suction syringe: 7 ml Plunger slide: 35 mm Guide needle size: L=50 to 80 mm or without Guide needle tip: Lancet point or blunt end Filter paper: size 20x35mm, 3 pieces

The provided text describes a 510(k) submission for a medical device, the "Sonopsy Aspiration Biopsy Needle." This type of submission establishes substantial equivalence to legally marketed predicate devices, rather than proving performance against specific acceptance criteria through a clinical study in the way a novel AI or diagnostic device might.

Therefore, the information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for training/test sets is not applicable to this type of regulatory submission.

Here's why:

• 510(k) for Substantial Equivalence: A 510(k) premarket notification demonstrates that a new device is "substantially equivalent" to a predicate device already legally marketed. This process primarily focuses on comparing the new device's technological characteristics and intended use to the predicate, rather than conducting new clinical trials to establish performance against pre-defined clinical acceptance criteria.
• Device Type: The Sonopsy Aspiration Biopsy Needle is a Class II gastroenterology-urology biopsy instrument. These are typically mechanical devices where performance is assessed through bench testing (e.g., needle sharpness, strength, material compatibility) and comparison of specifications to predicate devices. Clinical studies with human subjects to determine performance metrics like sensitivity, specificity, or accuracy (as would be relevant for an AI diagnostic tool) are generally not required for this type of device to obtain 510(k) clearance.

The key takeaway from the provided text is that the device was deemed substantially equivalent to the predicate devices listed (INRAD/MANAM Accucore Biopsy Needle, E-Z-EM, INC. Lufkin Aspiration Needle, DAUM Corp. DAUM Aspiration Needle) based on its technological characteristics and intended use, which is sufficient for 510(k) clearance.

If this were an AI-powered diagnostic device, a much more comprehensive study section detailing the points you've listed would be present.

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